Estriol, Unconjugated, Serum
NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.
A part of the QUAD/81149 Quad Screen (Second Trimester) Maternal, Serum) in biochemical second trimester or cross-trimester screening for Down syndrome and trisomy 18 syndrome
A marker of fetal demise
An element in the prenatal diagnosis of disorders of fetal steroid metabolism, including Smith-Lemli-Opitz syndrome, X-linked ichthyosis and contiguous gene syndrome (placental sulfatase deficiency disorders), aromatase deficiency, primary or secondary fetal adrenal insufficiency, and various forms of congenital adrenal hyperplasia
The assessment of preterm labor risk
Epidemiological studies of breast cancer risk in conjunction with measurement of estrone, estradiol, and various metabolites
Assessing estrogen metabolism, estrogen and estrogen-like medications, and other endogenous or exogenous factors impacting on estrogen metabolism in the context of other basic scientific and clinical studies
Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name
Estriol, Unconjugated, S
UE3 (Unconjugated Estriol)
UE3 (Unconjugated Estriol)
Specimen Type Describes the specimen type needed for testing
Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.
Preferred: Red top
Acceptable: Serum gel
Specimen Volume: 0.6 mL
Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.
Mild OK; Gross reject
Mild OK; Gross OK
Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.
|Serum||Refrigerated (preferred)||14 days|
Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test
Estrogens are involved in development and maintenance of the female phenotype, germ cell maturation, and pregnancy. They also are important in many other nongender-specific functions in men and women. These include growth, nervous system maturation, bone metabolism, and endothelial responsiveness.
There are 3 major biologically active estrogens in humans: estrone (E1), estradiol (E2), and estriol (E3). Like all members of the steroid hormone family, they diffuse into cells and bind to specific nuclear receptors, which in turn alter gene transcription in a tissue specific manner. E2 is the most potent natural human estrogen, closely followed by E1, while E3 possess only 20% of E2's affinity for the estrogen receptor. In men and nonpregnant women, E1 and E2 are formed from the androgenic steroids androstenedione and testosterone, respectively. E3 is derived largely through conversion of E2, and to a lesser degree from 16a-metabolites of E1. E2 and E1 can also be converted into each other, and both can be inactivated via hydroxylation and conjugation.
During pregnancy E3 becomes the dominant estrogen. The fetal adrenal gland secretes dehydroepiandrosterone-sulfate (DHEAS), which is converted to E3 in the placenta and diffuses into the maternal circulation. The half-life of unconjugated E3 (uE3) in the maternal blood system is 20 to 30 minutes, since the maternal liver quickly conjugates E3 to make it more water soluble for urinary excretion. E3 levels increase throughout the course of pregnancy, peaking at term.
Measurement of serum E2 and E1 levels is an integral part of assessment of reproductive function in females, and also has applications in both men and women in osteoporosis risk assessment and monitoring of female hormone replacement therapy. By contrast, with the exception of epidemiological studies assessing breast cancer risk and other scientific studies, the main value of E3 measurements is in the diagnosis of maternal-fetal diseases. In those settings, measurement of serum uE3 levels plays a major role.
Decreased 2nd trimester uE3 has been shown to be a marker for Down and trisomy-18 syndromes. It also is low in cases of gross neural tube defects such as anencephaly. Based on these observations, uE3 has become a part of multiple marker prenatal biochemical screening, together with alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG), and inhibin-A measurements (#81149 Quad Screen (Second Trimester) Maternal, Serum). Low levels of uE3 also have been associated with pregnancy loss, Smith-Lemli-Opitz syndrome (defect in cholesterol biosynthesis), X-linked ichthyosis and contiguous gene syndrome (placental sulfatase deficiency disorders), aromatase deficiency, and primary or secondary fetal adrenal insufficiency.
High levels of uE3, or sudden increases in maternal uE3 levels, are a marker of pending labor. The rise occurs approximately 4 weeks before onset of labor. Since uE3 has been shown to be more accurate than clinical assessment in predicting labor onset, there is increasing interest in its use in assessment of pre-term labor risk.
High maternal serum uE3 levels may also be occasionally observed in various forms of congenital adrenal hyperplasia.
Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.
Males: <0.07 ng/mL
Females: <0.08 ng/mL
In the context of the quad test, the measured uE3 value forms part of a complex, multivariate risk calculation formula, using maternal age, gestational stage, and other demographic information, in addition to the results of the 4 tested markers, for Down syndrome, trisomy 18 syndrome, and neural tube defect risk calculations.
A serum uE3 below 0.3 multiples of the gestational age median in women who otherwise screen negative in the quad test, indicates the possibility of fetal demise, Smith-Lemli-Opitz syndrome, X-linked ichthyosis or contiguous gene syndrome, aromatase deficiency, or primary or secondary (including maternal corticosteroid therapy) fetal adrenal insufficiency.
An elevated serum or uE3 above 3 multiples of the gestational age mean, or with an absolute value of more than 2.1 ng/mL, can be an indication of pending labor or fetal congenital adrenal hyperplasia.
In the context of assessment of a patient deemed at risk of preterm labor, a single serum or uE3 measurement within the above cutoffs, has a negative predictive value of labor onset (ie, labor unlikely within the next 4 weeks) of 98% in low-risk populations and of 96% in high-risk populations.
Measurements of serum uE3 performed in the context of epidemiological or other basic or clinical scientific studies need to be interpreted in the context of those studies. No overall guidelines can be given.
Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances
Like any immunoassay, this test can occasionally be subject to analytical interferences. We strive to identify and resolve these rare problems whenever they occur, but if the clinical picture is inconsistent with the test results, clinicians should still consider the possibility of a preanalytical or analytical error and contact the Automated Immunoassay Laboratory for discussion.
Method Description Describes how the test is performed and provides a method-specific reference
The instrument used is the Beckman Coulter UniCel DxI 800. The Access unconjugated estriol assay is a competitive binding immunoenzymatic assay. A sample is added to a reaction vessel with estriol-alkaline phosphatase conjugate, paramagnetic particles coated with goat anti-rabbit IgG, and polyclonal rabbit anti-estriol. Estriol in the sample competes with estriol-alkaline phosphatase conjugate for a limited number of binding sites on the specific anti-estriol antibody. After incubation in a reaction vessel, materials bound to the solid phase are held in a magnetic field while unbound materials are washed away. Then the chemiluminescent substrate Lumi-Phos*530 is added to the vessel and light generated by the reaction is measured with a luminometer. The light production is inversely proportional to the concentration of estriol in the sample. (Instrument Manual: Beckman Coulter Access Unconjugated Estriol Assay, 2010)
Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.
Monday through Friday; 5 a.m.-12 a.m., Saturday; 6 a.m.-6 p.m.
Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.
Same day/1 day
Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result
Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location The location of the laboratory that performs the test
Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.
This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.
CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.
LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.
|Result ID||Reporting Name||LOINC Code|
|UE3||Estriol, Unconjugated, S||2250-9|